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To assess if paracervical block is effective at reducing discomfort during placement of intracervical laminaria for pre-operative cervical preparation.
Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S) is commonly done prior to pregnancy termination to make the procedure safer. This study seeks to assess whether paracervical blocks are effective at reducing pain associated with placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are effective at reducing overall procedural pain and increasing overall patient satisfaction for the intracervical laminaria placement procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical Block with lidocaine | Active Comparator | A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. |
|
| Sham paracervical block | Sham Comparator | A sham block will be done prior to the placement of laminaria using a capped needle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracervical Block with lidocaine | Drug | Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain After Placement of Laminaria (100 mm Visual Analog Scale) | We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. | Measured within 10 seconds after placement of laminaria |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) | Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied | 15 minutes post-operatively |
| Paracervical or Sham Block Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Principal Investigator | University of Hawaii | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Women's Health Specialists | Honolulu | Hawaii | 96826 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6708260 | Background | Grimes DA, Schulz KF, Cates WJ Jr. Prevention of uterine perforation during curettage abortion. JAMA. 1984 Apr 27;251(16):2108-11. | |
| 22525915 | Background | Renner RM, Nichols MD, Jensen JT, Li H, Edelman AB. Paracervical block for pain control in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2012 May;119(5):1030-7. doi: 10.1097/AOG.0b013e318250b13e. |
| Label | URL |
|---|---|
| Summary of lidocaine drug information | View source |
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Participants recruited from May 2015 to Dec 2015 at two of the faculty practice offices of the University of Hawaii Department of OB/gyn.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracervical Block With Lidocaine | A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion |
| FG001 | Sham Paracervical Block | A sham block will be done prior to the placement of laminaria using a capped needle Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paracervical Block Group | Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria. |
| BG001 | Sham Block Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain After Placement of Laminaria (100 mm Visual Analog Scale) | We asked the participant to rate her pain on a 100 mm Visual Analog Scale (VAS) immediately after laminaria was placed. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. | Posted | Median | Inter-Quartile Range | units on a scale (100 mm VAS) | Measured within 10 seconds after placement of laminaria |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paracervical Block With Lidocaine | A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate. Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Reni Soon, MD | University of Hawaii | 808-203-6548 | rsoon@hawaii.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000773 | Anesthesia, Obstetrical |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000083 | Acetanilides |
| D000813 | Anilides |
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|
| Sham paracervical block | Drug | A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes |
|
|
Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. |
| Within 10 seconds after receiving paracervical or sham block |
| 15288222 | Background | Kan AS, Ng EH, Ho PC. The role and comparison of two techniques of paracervical block for pain relief during suction evacuation for first-trimester pregnancy termination. Contraception. 2004 Aug;70(2):159-63. doi: 10.1016/j.contraception.2004.03.013. |
| 25139724 | Background | Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23. |
| 22682721 | Background | Borgatta L, Roncari D, Sonalkar S, Mark A, Hou MY, Finneseth M, Vragovic O. Mifepristone vs. osmotic dilator insertion for cervical preparation prior to surgical abortion at 14-16 weeks: a randomized trial. Contraception. 2012 Nov;86(5):567-71. doi: 10.1016/j.contraception.2012.05.002. Epub 2012 Jun 6. |
| 24560477 | Background | Drey EA, Benson LS, Sokoloff A, Steinauer JE, Roy G, Jackson RA. Buccal misoprostol plus laminaria for cervical preparation before dilation and evacuation at 21-23 weeks of gestation: a randomized controlled trial. Contraception. 2014 Apr;89(4):307-13. doi: 10.1016/j.contraception.2013.10.013. Epub 2013 Nov 4. |
| 16055570 | Background | Goldberg AB, Drey EA, Whitaker AK, Kang MS, Meckstroth KR, Darney PD. Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial. Obstet Gynecol. 2005 Aug;106(2):234-41. doi: 10.1097/01.AOG.0000168629.17326.00. |
| 17963864 | Background | Prairie BA, Lauria MR, Kapp N, Mackenzie T, Baker ER, George KE. Mifepristone versus laminaria: a randomized controlled trial of cervical ripening in midtrimester termination. Contraception. 2007 Nov;76(5):383-8. doi: 10.1016/j.contraception.2007.07.008. Epub 2007 Oct 4. |
| 2359559 | Background | Hakim-Elahi E, Tovell HM, Burnhill MS. Complications of first-trimester abortion: a report of 170,000 cases. Obstet Gynecol. 1990 Jul;76(1):129-35. |
| 7121936 | Background | Blanco LJ, Reid PR, King TM. Plasma lidocaine levels following paracervical infiltration for aspiration abortion. Obstet Gynecol. 1982 Oct;60(4):506-8. |
| 28697113 | Derived | Soon R, Tschann M, Salcedo J, Stevens K, Ahn HJ, Kaneshiro B. Paracervical Block for Laminaria Insertion Before Second-Trimester Abortion: A Randomized Controlled Trial. Obstet Gynecol. 2017 Aug;130(2):387-392. doi: 10.1097/AOG.0000000000002149. |
Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participants were allowed to mark more than one race | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
A sham block will be done prior to the placement of laminaria using a capped needle Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes |
|
|
|
| Secondary | Satisfaction With Overall Pain Control (100 mm Visual Analog Scale) | Patients rated their satisfaction with overall pain control on the 100 mm VAS, with 0 as not satisfied at all and 100 as completely satisfied | Posted | Median | Inter-Quartile Range | units on a scale (100 mm VAS) | 15 minutes post-operatively |
|
|
|
|
| Secondary | Paracervical or Sham Block Pain | Participants reported her pain level on the 100 mm Visual Analog Scale (VAS) within 10 seconds after she received either the paracervical block or the sham block. The VAS is a validated measure of pain where 0=no pain and 100=worst pain ever felt. | Posted | Median | Inter-Quartile Range | units on a scale (100 mm VAS) | Within 10 seconds after receiving paracervical or sham block |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sham Paracervical Block | A sham block will be done prior to the placement of laminaria using a capped needle Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes | 0 | 21 | 0 | 21 |
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| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |